FDA.reportPublic FDA data

Buxton BioMedical

Primary DI
B7685683090
Brand
Buxton BioMedical
Company
Buxton Biomedical Inc
Model
56-8309
Catalog number
56-8309
Device description
Bone Tamper, 9mm diameter
Published
2024-04-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B7685683090PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical malletA hand-held manual surgical instrument designed to strike a surface or another device (e.g., a surgical chisel, gouge, driver) to drive it during a surgical intervention. It is available in a variety of designs and materials; the shaft is typically made of metal (e.g., chromed iron (Fe) or high-grade stainless steel), but can be made of synthetic materials (e.g., Tufnol), and tapers distally to the head. The head is typically a solid, cylindrical shape normally being double-ended and made of solid (iron/steel) or shock-absorbing materials (e.g., rubber, plastic, or Tufnol). Also referred to as a surgical hammer it may also be used for autopsy. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
808385207
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B7681901210Buxton BioMedical190-121190-1212023-07-07
B7683439140Buxton BioMedical34-391434-39142026-04-24
B7685674460Buxton BioMedical56-744656-74462026-04-24
B7685676080Buxton BioMedical56-760856-76082026-04-24
B7685677060Buxton BioMedical56-770656-77062026-04-24
B7682462200Buxton BioMedical24-622024-62202026-04-23
B7683434130Buxton BioMedical34-341334-34132026-04-23
B7687417000Buxton BioMedical74-170074-17002026-04-23
B7687684070Buxton BioMedical76-840776-84072026-04-23
B7688386020Buxton BioMedical83-860283-86022026-04-23
B7688441030Buxton BioMedical84-410384-41032026-04-23
B76884751040Buxton BioMedical847-5104847-51042026-04-23
B76884754320Buxton BioMedical847-5432847-54322026-04-23
B7688532061030Buxton BioMedical853-20-6103853-20-61032026-04-23
B7688532351120Buxton BioMedical853-23-5112853-23-51122026-04-23
B7688532351130Buxton BioMedical853-23-5113853-23-51132026-04-23
B7688650540Buxton BioMedical86-505486-50542026-04-23
B7688441020Buxton BioMedical84-410284-41022025-12-31
B7688457751630Buxton BioMedical845-77-5163845-77-51632025-12-31
B76885362280Buxton BioMedical853-6228853-62282025-12-31

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Primary DI, Brand, Company table
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